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Quality Management for Medical Devices – ISO 13485:2016

4.5/5
(54 reviews)
Quality Management ISO13485

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : Quality Management for Medical Devices – ISO 13485:2016

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes

This an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.

This online training also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services

 

Curriculum:

 

Lesson 1: What is a medical device ?

 

Lesson 2: What is a quality management system ?

 

Lesson 3: What benefits will it bring to my organization ?

 

Lesson 4: Why was ISO13485 revised ?

 

Lesson 5: What are the key improvements ?

 

Lesson 6: I am certified to ISO 13485:2003. What does it mean for me ?

 

Lesson 7: Relationship with ISO 9001

 

Glossary

 

Evaluation

Author:

ciaran
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

4.5/5
(54 reviews)
Great for pharmaceutical professionals who are interested in ISO 13485. As someone without prior knowledge with medical device or QMS, this is an excellent e-learning content to learn more about ISO 13485. I am looking forward to getting my company onboard with Standard's range of cloud solutions.
Kevin PattonQuality Manager
USD: United States (US) dollar ($) ^

$95

Buy now

  Large group ? Request a quote !

This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

  • Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
  • Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
  • Self-paced : access 24/7 to the course during 12 months at your own rhythm.
  • Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
  • Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
  • Instant Purchase : one click to buy and immediate access. Get certified today.
  • LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
  • HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
  • Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
  • LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.
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$95.00 / year

$95.00 / year

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About us

GxP Training is a service provided by Axeda SRL, a recognized leader in digital regulatory learning. Axeda specializes in compliance training and assessment solutions specifically designed for life sciences companies and professional training organizations.

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